The objective of this study is to test the efficacy hypothesis that extended cryoballoon ablation is superior to either standard cryoballoon ablation or radiofrequency ablation
The posterior wall of the left atrium is known to contribute to arrhythmogenicity and has been associated with higher rates of atrial fibrillation (AF) recurrence. In this trial, we aim to evaluate whether extended cryoballoon ablation-comprising pulmonary vein isolation (PVI) plus posterior wall isolation-results in superior rhythm outcomes compared to standard cryoballoon ablation (PVI only) or radiofrequency ablation (PVI only). Patients will be randomly assigned to one of three treatment arms: extended cryoballoon ablation, standard cryoballoon ablation, or radiofrequency ablation. Each patient will receive the assigned treatment accordingly. The primary outcome is the incidence of atrial tachyarrhythmias-including atrial fibrillation, atrial flutter, and atrial tachycardia-lasting more than 30 seconds, occurring after discontinuation of antiarrhythmic drugs and following a 3-month post-procedure blanking period. Outcomes will be compared at 1 year after the procedure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
288
Radiofrequency ablation of pulmonary veins
Cryoablation of pulmonary veins + posterior wall isolation
Standard cryoablation of pulmonary veins
Seoul National University Bundang Hospital
Seongnam-si, South Korea
Asan Medical Center
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
the incidence rates of atrial tachyarrhythmias
Incidence of atrial tachyarrhythmias (including atrial fibrillation, flutter, or tachycardia) lasting \>30 seconds after discontinuation of antiarrhythmic therapy, assessed following a 3-month blanking period
Time frame: 3-month blanking period post-procedure
Atrial arrhythmia recurrence during blanking period
Atrial arrhythmia recurrence during blanking period (3 months) after one or two procedures with/without antiarrhythmic medications
Time frame: during blanking period (3 months)
Atrial tachycardia or flutter recurrence
Atrial tachycardia or flutter recurrence during long-term follow-up after one or two procedures with/without antiarrhythmic medications
Time frame: 1 year
Atrial fibrillation recurrence
Atrial fibrillation recurrence during long-term follow-up after one or two procedures with/without antiarrhythmic medications
Time frame: 1 year
Incidence of peri-procedural complications
including stroke, cardiac tamponade, esophageal injury, phrenic nerve damage, and death
Time frame: Periprocedural
Rate of first-pass isolation or first-freeze isolation
Time frame: during procedure
Procedure duration (minutes)
Time frame: during procedure
Ablation time (minutes)
Time frame: during procedure
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Fluoroscopy time (minutes)
Time frame: during procedure
LA dwelling time
Time frame: during procedure
Ablation time (seconds)
Time frame: during procedure
Quality of life changes at 12 months compared to baseline
Scores from the SF-36 questionnaire will be compared between baseline and the 1-year follow-up period. Scores will be scaled from 0 to 100, with higher values indicating better quality of life
Time frame: 1 year
Number of repeat procedures
Time frame: 1 year
AF burden by 2-week patch monitoring
AF burden assessed at 12 months after ablation
Time frame: 1 year
LA pressure, mmHg (max/min/mean)
Time frame: during procedure